PT93490B - SYSTEM OF LIBERATION OF DRUGS INTRA-ORAL ADMINISTRATIONS - Google Patents

Abstract

A system for long term releasing of medication in the mouth, and especially an intra-oral fluoride releasing system (IFRS) for releasing fluoride over a long term for inhibiting the formation of caries in the teeth. The system uses a holder (10,130) for retaining and protecting intra-oral fluoride tablets (100) or other intra-oral medicament in the form of fluoride releasing devices (IFRD). The holder (10,130) has a plate (30) with retaining sides (40,140) and retaining posts (50,150,155) or a carrier. The tablet (100) will fit within the holder (10,130). The tablet (100) may be located in the carrier, or ligature bands (200) can be tied around the tablet (100) in order to releasably hold the IFRD within the holder (10,130). The system causes a level of fluoride to be maintained over a long term within the mouth which has been found chemically effective for caries control and without causing severe irritation to oral tissues.

Description

ii The present invention generally relates to systems for retaining and destroying means of preventing caries (fluoride) intraorally for a slow and controlled release to teeth by saliva over a long period of time (weeks or months) and users for use inside the mouth that retain and protect a fluoride intraoral release device || (IFRD). The combination of an IFRD and its support constitutes a r

fluoride intraoral delivery system (IFRS). This invention; tion is generally useful in holders for intraoral .comprimidos drugs with long release times in the mouth without significant irritates ¹ dog oral tissue.

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'BACKGROUND OF THE INVENTION

Dental research has been remarkably successful in preventing tooth decay. Specifically, it has been found that approximately 50% of children aged 6 to 17 years old who live in the United States do not have tooth decay. This remarkable progress over the past 20 years is due, in part, to better oral hygiene, use of fluorinated water, and fluorinated products, i.e. toothpaste. However, there are patients who remain susceptible to tooth decay. For example, 20% of all children are responsible for approximately 60% of all lesions with cavities. In addition, certain individuals with impaired salivary function are especially candidates for cavities, due to the production of limited amounts of saliva. Other risk factors such as poor oral hygiene, physical or mental disabilities, and certain systemic diseases can also predispose individuals to dental caries.

Recent studies have shown that high concentrations of fluoride in the mouth over long periods help to reduce caries. One source of this fluoride is contained in controlled-release fluoride tablets that have been designated as intraoral fluoride (IF) RD delivery devices. These fluoride release devices of the IFRD type in the oral cavity for long periods and up to six months increase the prevention of tooth decay.

Previous attempts to retain IFRD in the mouth have failed for several reasons. For example, IFRDs produced by the Southern Research Institute are designed to be attached directly to teeth. These IFRDs were found to be liable to disintegrate by chewing forces or to be subject to excessive wear and tear caused by abrasives contained in toothpaste. What is desirable, however, is a system in which IFRD tablets can be safely held and kept in the mouth until their fluoride content has been released.

• • In addition, it is desirable to have a system (a system • i

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intraoral fluoride release system or IFRS) with which;

: primitives can be replaced periodically after the end of ι ί; _ I

Only its fluoride content. It is also desirable that these systems are useful for children who are undergoing an active orthodontic treatment. In general, these children are at a higher risk of developing cavities since they are no longer able to brush their teeth properly. It is also desirable to provide an IFRS that does not cause severe irritation to the tissues of the mouth. What is meant by severe irritation is acute ulceration or inflammation that interferes with oral function and nutrition, such as pain. , decomposition or ι I 'necrosis or purulent tissue exudate in the vicinity of IFRS.

SUMMARY OF THE INVENTION i!

'1 Thus, it is a main object of this invention to provide an IFRS in which the problems mentioned above;

Idos and their treatment needs are resolved and more particularly to provide intra-oral IFRD supports that can be safely placed and retained in the mouth for an indefinite period.

| In a brief summary, a system according to (the invention comprises a support having a retaining element,) as for example a plate or band, with a posterior surface adapted to be fixed to the surface of a tooth. This rear surface is connected to a pair of opposite retaining walls within which the tablet can be placed, either directly on the plate or in a vehicle releasably connected to the plate. At the ends of the opposite retaining walls there are a pair of retaining pins. These pins can be rodeaJidas with strips, which extend over the tablet so that the tablet ¹ is exposed in the mouth but in permeneça support portion denj position. A cover can be fitted which can be opened and extended through the retaining wall. Fluoride is placed in the oral cavity by IFRD tablets at therapeutic values that remain in the mouth for up to six months. The IFRD can be lifted. Installed by removing and replacing the strips or opening the cover

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removing and re-inserting the vehicle with a new tablet, or replacing the system (the IFRD and the support) completely.

These and other objectives and achievements of the invention will be better understood with the attached figures and a detailed description of the drawings in which:

DETAILED DESCRIPTION OF THE DRAWINGS

Fig. 1 - is a perspective view of a first embodiment according to the invention that is attached to a tooth;

) Fig. 2 - is an exploded perspective view of the embodiment of the invention shown in Fig. 1 with a fluoride tablet;

Fig. 3 - is a top view of the support retaining element of the embodiment of the invention shown in Fig. 1;

Fig. 4 - is a side elevation view of the retaining element shown in Fig. 3;

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Fig. 5 - is a front view of the retaining element shown in Fig. 3;

Fig. 6 - is a perspective view of another realization of the retaining element;

Fig. 7, 7B and 7C are perspective views of variations of a second embodiment according to the present invention;

Fig. 7A is a sectional view through line 7—7 of the embodiment shown in Fig. 7;

Fig. 8 is a perspective view of a third embodiment according to the present invention; and

Fig. 9A, 9B, 9C are respectively a perspective view and two side views of a fourth embodiment of the invention.

DETAILED DESCRIPTION OF THE INVENTION

As can be seen from Figures 1, 2, 3, 4 and 5, according to a first embodiment of the present invention, an IFRS with a support 10 for tablets that can be placed in the mouth is provided. These tablets are generally compressed. · «-En« uonfi

['controlled-release fluoride dosages and are oval-shaped or! i | beans like the 100 tablet you can see

Fig. 2. The support 10 is generally constituted by a strip 20 'that surrounds the tooth and a retaining element R. This retaining element R will generally consist of a plate 301 | having a back surface that is bonded, for example

I by spot welding, the band 20. The element R has retaining walls 40, which are best seen in Figs. 2 and 3. The tablet 100 is generally accommodated within the retaining walls 40 and against the front surface of the support 10. The posterior surface of the plate may be spat out to conform to the outer surface of the tooth.

'i ^! [To secure the attachment of the tablet 100 to the holder 10, the plate 30 has a pair of retaining pieces 50. These J pieces 50 have round projections 55, usually with indentations

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j. around which miniature elastic strips, known as bandage bands 200, can be attached. When the tablet 100 is inserted into the holder 10, the bandage bands 200 are placed around (around the projections 55 in order to accommodate the tablet 100 ji

I inside the support 10, as can be seen better in Fig. 1. The band í;

'20 is then generally applied around the tooth. Instead of (ligature bands, stainless steel wires may be used, and the term ligatures or ligature bands should be understood as encompassing endless strips and wires.

[i The application method will be as follows: 0 tooth! i will usually have separators placed in the interdental spaces

Jl to gain space for dental ligament in order to be able to insert • jl • band 20. Band 20 is then inserted around the den

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and forced to stick to it. The tablet 100 is placed on the plate 30 of the support 10. The bandage bands 200 are placed around the protrusions of the retaining part 55 and allow the tablet to be releasably retained and protected in the mouth. As can be seen, if the intraoral fluoride tablet 100 breaks in the mouth or its fluoride content is released, the bandage bands 200 can be removed, and a new tablet 100 can be inserted in the support 10. From this In this way, the support 10 can have any necessary residence time in the mouth depending on the desired dental procedure.

Another support 10 can be seen in Fig. 6 having a retaining element 130 in a band 120. Although the retaining element 30 shown in Fig. 1-5 is generally oval to accommodate an oval shaped tablet, element 130 in the Fig. 6 is generally rectangular. This element will hold a tablet with a generally rectangular shape in position. As can be seen, the web 120 has the back surface of the base plate of the retaining element 130 attached to it. This support 130 has two retaining walls 140 and two retaining parts ί - <150. The pair of retaining pieces is placed between the two retaining walls 140. On each retaining piece 150 there are projections 155, around which bandages 200 can be attached, as shown in Fig. 1-5 . So, one puts up with

I press the rectangular shape against the base plate of element 130 and between its retaining walls 140. Then, the banding bands 200 are wound around the projections of the retaining pieces 155. Again, the device remains around the tooth and makes hygienic treatment possible.

As can be seen in Fig. 7 and Fig. 7A, a support 210 is provided having a band 220 which has a retaining element 230 attached to it having a plate 231 with loop 231a, 231b. The rear surface of the plate 231 is connected to the band 220. The plate 231 has connected to it a pair of retaining walls 231a, 231b. The retaining walls 231a, 231b each have a notch 242, containing a shoulder 242a. The retaining element 230 receives a slide 250 with a flan

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267 that are received inside the slots 242. The shoulder j

242a in the notch 242 is consistent with the shoulder 267a flange 267 to hold the drawer 250 in position. This drawer 250 is generally rectangular and will contain a front grille 260 and a pair of side grilles 265. A retaining bridge 252 on plate 231 holds the drawer in position with the projection 251 on the flange 267 of the drawer 250 in the position shown, to prevent sliding forward with an extension piston.

The front and side louvers 260, 265, con!

it has openings sufficiently wide so that an I IFRD tablet comes into contact with saliva in the mouth. Since the notches 242 allow the drawer 250 to slide in and out, the tablet 100 can be placed inside the drawer 250 and then slide into the notches. Drawer 250 can be removed and a new tablet 100 can be inserted, thus allowing an indefinite period of reuse.

Alternatively, drawer 250 can be secured by bandage bands 200 as shown in Fig. 7B. In the ^first _ 'prospectus of this embodiment, the retaining walls 240 contain retaining parts 255 very similar to the retaining parts 50, 150 of the previous embodiments. After placing the drawer 250 on the retaining walls 240 with a tablet 100 in position, the gave 250 is held by the bandages 200.

Obviously, as can be seen in Fig. 7C, the device of the present invention can be configured in such a way that the retaining walls and the drawer form a unique retaining unit with a grid shape 270. This retaining unit 270 has an open side where the tablet 100 is placed. The bandages 200 are then rolled over the opening of the holding unit, and fixedly fixed around the pieces 255. The operation of the support will be identical to the previous embodiments.

Another third embodiment of the invention can be seen in Fig. 8. This embodiment provides a support 310 that can be used together with ortho dental arms. dency (represented as 331 arms) that are connected to a

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ι ^;

μ ί'banda 333. As can be seen in Fig. 8, there is a retaining element with the oval or rectangular shape 330 with a cage or retaining wall 340 that generally adapts to the shape of one; of intraoral fluoride (IFRD) tablets. This retaining wall 340 has a support plate to which a pin 360 is attached. One end 361 of this pin extends through one side of the cage 340. The other end 365 of the pin 360 is Z-shaped for allow an optional range of intraoral placement. The Z-shaped end 365 can be inserted into one of the dental arms 331 which provides an arcuate slot. Alternatively, the cage 340 can be attached to the tooth directly by means of an adhesive. Or, the back}

The base plate of the support element 330 can be fixed using a band as in the system shown in Figs. 1-7.

This support 310 has a cover made of flexible material 350 containing a net 345. This cover has fingers 348 that wrap around a rod 347, connected to the bottom side of a cage 340 that forms a joint. On cover 350 there is also a hold 349. This hold can hold a protrusion 351 on the top side of the cage that causes the cover to attach to the gauge and cover its front. Thus, the co-opening can be opened and the tablet can be inserted into the retention cage 340. This support 310 can be removed e ^! used more than once (ie for other patients or removed for other supports in another part of the mouth). This makes this realization versatile and may be preferred for patients who need or have other orthodontic applications.

Finally, it can be seen in Figs. 9A-9C is a fourth embodiment of the present invention. A support 410 is shown having a pair of side retaining walls or bands 420 which are wound around the tooth. In the band 420 a rear surface 430 is welded having folding hooks {440. These hooks 440 can rotate around the pins 450 to allow the placement of the tablet 100 on the rear surface 430. When in position the hooks are approached and held. tightened by winding the band ligation bands around it ^! for hooks 440.

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In this way the support 410 retains properly and exposes a tablet for use. Alternatively, hooks 440 can be connected with a longitudinal bar. If so, a spring clip as shown in fig. 8 to retain the IFRD tablet in holder 410.

It should be noted that all designs of the supports are preferably made of aluminum or another high-strength metal (for example stainless steel), or, alternatively, of a non-degradable, bio-compatible hardened plastic. Chewing in the mouth, in contact with the material must withstand the forces of and still allow large areas covered with saliva to allow the release of fluoride into the mouthpiece.

Claims (4)

1. System for replacing and replacing a controlled-release intraoral tablet such as an intraoral fluoride device, characterized in that the system comprises: a band or fixation for a tooth, a support fixed to said band and having a plate on which the tablet can be placed, and a retention system connected to the support to replace and protect the tablet replacably when it is placed on the plate, wherein the restraint system comprises either a pair of opposing retaining walls (40) and a pair of retaining brackets (50) placed between the retaining walls (40) on which a loop (200) can be placed for hold the tablet (100) against the plate (30), or - 9 BNSDOCID: <PT 93490B> '7 - a pair of opposite retaining walls (231a, 231b) between which a drawer (250) rests to hold the tablet (100), which drawer (250) is provided with at least one grid (260,265) through which the compressed (100) can i be exposed to the outside of the support (210), or a pair of opposite retaining walls (340) and a cover (350) articulated with one of said pairs of retaining walls and closing in the other of said pairs of retaining walls to hold the tablet (100) placed on the plate (330) between the retaining walls (340), or) a pair of opposite retaining walls (420) and several hinged claws (440) placed between the retaining walls (420) and that can be rotated to allow the tablet to be placed on the plate (430) when the claws (440) are in the open position, and to hold the tablet placed on the plate (430) when the claws ( 440) are in the closed position, where said support allows the co The tablet dissolves in the saliva and simultaneously protects the tablet from the forces of chewing. A system according to claim 1 wherein the pair of retaining brackets (50) are provided with retaining heads (55) for retaining said loop (200). System according to claim 1 or 2, in which the plate on which the tablet can be placed is generally oval in shape. A system according to claim 1 or 2, wherein the plate on which the tablet can be placed is generally rectangular in shape. i The applicant claims the priorities of the North American applications submitted on March 20, 1989, - io3NSDOCIO ·. <PT 93490B> I: ι ι | -.1 and on June 2, 1 989 under the serial numbers ι : respectively.